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Agenda
Reg Review
ICR
Information Collection List
IC Title
Status
Responses
Hours
Dollars
Document Type
Form No.
Form Name
Biologics; Licensing; General Biological Products Standards; and Additional Standards
Modified
67117
813017
0
Form and Instruction
Form FDA 2253
TRANSMITTAL OF ADVERTISEMENTS AND PROMOTIONAL LABELING FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form and Instruction
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Form
Form FDA 2252
TRANSMITTAL OF ANNUAL REPORTS FOR DRUGS AND BIOLOGICS FOR HUMAN USE
Other-Agency Guidance
Form
FDA 356h
Application to Market a New Drug or Abbreviated New Drug or Biologic for Human Use
Instruction
Form
FDA 3988
Transmittal of PMR/PMC Submissions for Drugs and Biological Products
Instruction
Form
FDA 3989
PMR/PMC Annual Status Report for Drugs and Biological Products
Instruction
Form
FDA 3674
Certification of Compliance
Instruction
Notifications of suspensions
Unchanged
20
7
924
Form and Instruction
356h
Application to Market a New Drug or Biologic for Human Use
Total burden requested under this ICR:
67137
813024
924
To view an IC, click on IC Title